FDA.reportPublic FDA data

House Brand Dentistry

Primary DI
00810132802287
Brand
House Brand Dentistry
Company
House Brand Dentistry
Model
HSB-300111
Device description
HSB - Burnisher D/E #28/29 Smooth
Published
2024-01-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
EMFKnife, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMFKnife, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810132802287PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810132802287008101328022878101328022870810132802287

GMDN Terms#

Term, Definition table
TermDefinition
Manual dental burnisher, reusableA hand-held manual dental device with a smooth or ribbed working head intended to be used to create thin margins between a dental restoration and the enamel at the cavo-surface angle, and/or to polish the surface of metallic restorations by rubbing. Its terminus is round or ball-shaped and is typically made of metal. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
203768304
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810132809436House Brand DentistryHSB-4113002025-05-14
10810132809450House Brand DentistryHSB-4113022025-05-14
10810132809467House Brand DentistryHSB-4113032025-05-14
10810132809320House Brand DentistryHSB-4112082025-05-09
10810132809351House Brand DentistryHSB-4112112025-05-09
10810132809382House Brand DentistryHSB-4112142025-05-09
10810132809399House Brand DentistryHSB-4112152025-05-09
10810132808392House Brand DentistryHSB-4111082025-05-08
10810132808415House Brand DentistryHSB-4111102025-05-08
10810132808446House Brand DentistryHSB-4111132025-05-08
10810132808477House Brand DentistryHSB-4111172025-05-08
10810132808569House Brand DentistryHSB-4111282025-05-08
10810132808651House Brand DentistryHSB-4111392025-05-08
10810132808675House Brand DentistryHSB-4111412025-05-08
10810132808910House Brand DentistryHSB-4111782025-05-08
10810132808941House Brand DentistryHSB-4111782025-05-08
10810132808958House Brand DentistryHSB-4111792025-05-08
10810132809030House Brand DentistryHSB-4111502025-05-08
10810132809078House Brand DentistryHSB-4111832025-05-08
10810132809085House Brand DentistryHSB-4111842025-05-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08681506800350SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETIEMF2026-01-24
00848530100162Disposable Wire-Guided Scapel for Central Venous CannulationSUNSET HEALTHCARE SOLUTIONS, INC.EMF2025-12-09
00848530100179GuideBlade Sample KitSUNSET HEALTHCARE SOLUTIONS, INC.EMF2025-12-09
08681506801302SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETIEMF2025-12-09
08681506801227SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETIEMF2025-12-08
04046826114374Medicon TrayMedicon eG. Chirurgiemechaniker-GenossenschaftEMF2025-12-01
00190776404604MillenniumAvalign Technologies, Inc.EMF2025-07-10
00190776403058MillenniumAvalign Technologies, Inc.EMF2025-07-01
00190776403201MillenniumAvalign Technologies, Inc.EMF2025-07-01
08717903490280Humeca Silver knifeHumeca B.V.EMF2025-05-20
08717903490297Humeca Humby knifeHumeca B.V.EMF2025-05-20
08717903490303Humeca Cobbett knifeHumeca B.V.EMF2025-05-20
08717903490310Humeca Watson knifeHumeca B.V.EMF2025-05-20
08717903490327Humeca Humby long knifeHumeca B.V.EMF2025-05-20
00190776397616MillenniumAvalign Technologies, Inc.EMF2025-05-16
00190776393137MillenniumAvalign Technologies, Inc.EMF2025-05-05
04049047000143GimmiGimmi GmbHEMF2025-04-16
04049047000297GimmiGimmi GmbHEMF2025-04-16
04049047000303GimmiGimmi GmbHEMF2025-04-16
04049047000358GimmiGimmi GmbHEMF2025-04-16
04049047000365GimmiGimmi GmbHEMF2025-04-16
04049047000402GimmiGimmi GmbHEMF2025-04-16
04049047000426GimmiGimmi GmbHEMF2025-04-16
04049047000457GimmiGimmi GmbHEMF2025-04-16
04049047000549GimmiGimmi GmbHEMF2025-04-16
04049047000853GimmiGimmi GmbHEMF2025-04-16
04049047000860GimmiGimmi GmbHEMF2025-04-16
04049047000877GimmiGimmi GmbHEMF2025-04-16
04049047000884GimmiGimmi GmbHEMF2025-04-16